MSD and Eisai's combination of Keytruda and Lenvima has become a driver of growth for both products, but their efforts to extend the regimen into liver cancer have hit a hurdle.

默沙东和卫材的Keytruda与Lenvima联合疗法已成为这两款产品增长的驱动力，但他们试图将该方案扩展到肝癌领域的努力遇到了障碍。

The two partners said that dual therapy with PD-1 inhibitor

两位合作伙伴表示，使用PD-1抑制剂的双重疗法

Keytruda

Keytruda

(pembrolizumab) and tyrosine kinase inhibitor

(pembrolizumab) 和酪氨酸激酶抑制剂

Lenvima

乐伐替尼

(lenvatinib) in patients with hepatocellular carcinoma (HCC) – the most common form of liver cancer – was unable to achieve an increase in overall survival (OS) compared to placebo in the LEAP-012 study.

在肝细胞癌（HCC）患者中，最常见的肝癌形式，lenvatinib在LEAP-012研究中未能比安慰剂实现总生存期（OS）的延长。

The study, which compared the regimen to placebo given on top of transarterial chemoembolisation (TACE), a standard therapy for unresectable, non-metastatic HCC, was previously reported to have shown an improvement in progression-free survival (PFS), raising the hope that Keytruda/Lenvima could become an option for HCC..

该研究之前被报道显示无进展生存期（PFS）有所改善，这带来了Keytruda/Lenvima可能成为肝细胞癌（HCC）治疗选择的希望。该研究将这种方案与在经动脉化疗栓塞术（TACE）基础上加用安慰剂进行了比较，TACE是不可切除、非转移性肝细胞癌的标准治疗方法。

'Although the progression-free survival results from this study are encouraging, unfortunately, the addition of Keytruda plus Lenvima to TACE did not show the overall survival benefit we hoped,' said MSD's global clinical head, Dr Gregory Lubiniecki.

“尽管本研究的无进展生存期结果令人鼓舞，但遗憾的是，将Keytruda联合Lenvima加入TACE并未显示出我们所期望的整体生存益处，”MSD全球临床负责人Gregory Lubiniecki博士表示。

Lenvima monotherapy is already approved by the FDA as a first-line therapy for unresectable HCC, while Keytruda is a second-line option for patients previously treated with sorafenib, another TKI.

Lenvima单药疗法已被FDA批准作为不可切除HCC的一线治疗，而Keytruda是另一种TKI索拉非尼先前治疗过的患者的二线选择。

While the termination of the trial draws a line under efforts to develop Keytruda/Lenvima for unresectable, non-metastatic HCC in Western markets, the regimen has been approved for this indication in China based on the LEAP-012 PFS data.

虽然该试验的终止为在西方市场开发Keytruda/Lenvima用于不可切除、非转移性肝细胞癌的努力划上了句号，但该方案已基于LEAP-012的无进展生存期数据在中国获批用于这一适应症。

MSD, known as Merck & Co in the US and Canada, licensed rights to Lenvima in 2018 in a near-$6 billion deal aimed at developing it as a partner drug to Keytruda. The combination has been approved for kidney and endometrial cancers, but studies in other indications, including lung, oesophageal, colorectal and skin cancers, have disappointed..

默沙东（在美国和加拿大称为默克公司）在2018年以近60亿美元的价格获得了Lenvima的授权，目的是将其作为Keytruda的联合用药进行开发。该组合疗法已获批用于肾癌和子宫内膜癌，但在其他适应症的研究中，包括肺癌、食道癌、结直肠癌和皮肤癌，结果令人失望。

'For years, TACE has been a standard of care for these patients, yet many experience disease progression within 12 months,' said Dr Corina Dutcus, oncology global clinical development lead at Eisai. 'With LEAP-012, we sought to make a meaningful difference for this patient population.'

“多年来，TACE一直是这些患者的标准治疗方案，但许多患者在12个月内出现疾病进展，”卫材肿瘤学全球临床开发负责人Corina Dutcus博士表示。“通过LEAP-012，我们希望为这一患者群体带来有意义的改变。”

Welireg win

Welireg获胜

Earlier this week, MSD had better news from two trials of its HIF-2α inhibitor

本周早些时候，MSD的两项HIF-2α抑制剂试验带来了更好的消息。

Welireg

韦利雷格

(belzutifan), LITESPARK-011 and LITESPARK-022, in earlier lines of therapy for renal cell carcinoma, a common form of kidney cancer.

（belzutifan）、LITESPARK-011 和 LITESPARK-022，用于肾细胞癌早期治疗，这是一种常见的肾癌形式。

LITESPARK-011 showed that Welireg and Lenvima improved PFS compared to Exelixis' Cabometyx (cabozantinib) in RCC patients who had progressed after first-line PD-1/PD-L1 inhibitor therapy, while in LITESPARK-022, Welireg plus Keytruda extended PFS when compared to Keytruda plus placebo in the first-line setting..

LITESPARK-011 显示，在接受一线 PD-1/PD-L1 抑制剂治疗后病情进展的肾细胞癌患者中，Welireg 和 Lenvima 改善了无进展生存期（PFS），相较 Exelixis 的 Cabometyx（卡博替尼）；而在 LITESPARK-022 中，与 Keytruda 加安慰剂相比，Welireg 联合 Keytruda 在一线治疗中延长了 PFS。

Welireg is already approved as a second-line monotherapy for RCC and for two rare diseases that cause tumours, and has been tipped by some analysts as a future $1.5 billion-plus blockbuster if it can move earlier in treatment. Sales were just over $500 million last year.

Welireg 已被批准作为肾细胞癌（RCC）的二线单药治疗，以及两种引发肿瘤的罕见病治疗药物。如果它能在治疗中更早应用，一些分析师预测其未来可能成为一款年销售额超过 15 亿美元的重磅药物。去年其销售额刚刚超过 5 亿美元。